A Randomized, Double-Blind, Double-Arm Trial Comparing Desflurane to Sevoflurane for the Effect on Recovery Time in Patients Undergoing Urological Cystoscope Surgery Under General Anesthesia With a Laryngeal Mask Airway (LMA)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Recovery Time
研究概览
简要总结
This is a single-center, prospective, randomized, double-blind, double-arm trial including 68 subjects scheduled to undergo urological cystoscope surgeries under general anesthesia (GA) with intubation through a laryngeal mask airway (LMA) at The Ohio State University Medical Center (OSUMC). Double blinding will be based on both the subject and the research staff being unaware of which trial arm the subject is randomized into. Eligible subjects that provide voluntary and written informed consent will be included in this study.
详细描述
This is a single-center, prospective, randomized, double-blind, double-arm trial including 68 subjects scheduled to undergo urological cystoscope surgeries under general anesthesia (GA) with intubation through a laryngeal mask airway (LMA) at The Ohio State University Medical Center (OSUMC). Double blinding will be based on both the subject and the research staff being unaware of which trial arm the subject is randomized into. Eligible subjects that provide voluntary and written informed consent will be included in this study.
Day -14 to 0
Subjects will undergo screening procedures up to 14 days prior to administration of study treatment. The research staff will collect the subjects' medical history (including reason for surgery, scheduled surgical procedure, anesthesia modality, and scheduled surgery length), demographics (including gender, age, and race), allergies, history of smoking, history of alcohol or drug abuse, medications, history of postoperative nausea and vomiting (PONV), and history of motion sickness. A physical examination will also be performed at this time.
Day 0
Upon enrolment, subjects will be randomly assigned in a 1:1 ratio, from a pre-determined randomization schedule, by the research pharmacist to one of two anesthetic treatment groups: Anesthesia maintained under desflurane or anesthesia maintained under sevoflurane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 50 to 75 years of age.
- •Subjects with an American Society of Anesthesiologist (ASA) physical status of I to III.
- •Subjects able to provide written informed consent to participate in the study.
- •Female subjects who have a negative urine or serum pregnancy test, who have been surgically sterilized, or are postmenopausal.
- •Subjects scheduled for urological cystoscopic surgery under general anesthesia with LMA intubation.
排除标准
- •Subjects who are prisoners.
- •Subjects who have limited decision-making capacity or lack the ability to consent.
- •Subjects with a history of alcohol or drug abuse within the last year.
- •Subjects with a history of an allergic reaction, intolerance, or contraindications to any of the study medications.
- •Females who are pregnant or are breastfeeding.
- •Subjects with BMI greater than
- •Subjects with a history of hiatal hernia or gastroesophageal reflux disease (GERD).
- •Subjects with a history of pharyngeal pathology.
- •Subjects who have participated in or are currently participating in a clinical trial of an investigational drug within 30 days prior to surgery.
- •Subjects with a fixed decreased pulmonary compliance, such as patients with pulmonary fibrosis.
- •Subjects with multiple or massive injuries, acute abdominal and/or thoracic injuries.
- •Subjects with any condition associated with delayed gastric emptying.
- •Subjects who are profoundly unconscious and who may not resist LMA insertion or have a contraindication for the use of LMA intubation.
- •Subjects with any condition that in the opinion of the investigator would render the subject ineligible for participation in the study, such as unstable or severe cardiovascular, pulmonary, renal, hepatic, metabolic, or endocrine disease or neuromuscular disorder.
- •Subjects with a history of malignant hyperthermia.
研究组 & 干预措施
Desflurane
Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.
干预措施: Desflurane (Drug)
Sevoflurane
Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Recovery Time
时间窗: 14 Days
Recovery Time after exposure to desflurane or sevoflurane considering time of emergence from anesthesia
次要结局
- Difference in Time to Orientation(14 Days)
- Time to Extubation(14 days)
- Incidence of Coughing at Extubation, Approximately 10 Minutes After End of Surgery(At extubation, approximately 10 minutes after end of surgery)